Memoranda

Both Turkey and South Korea are working to implement chemical management programs to comply with broader international initiatives. In December 2009, Turkey implemented new legislation concerning the classification, labeling, and packaging (CLP) of dangerous substances and preparations, and a regulation on safety data sheets (SDS) for dangerous substances and preparations. South Korea has initiated a process for the management of chemicals, with the objective of minimizing the harmful effects...

On February 3, 2011, the Senate Committee on Environment and Public Works Subcommittee on Superfund, Toxics, and Environmental Health held a hearing entitled "Assessing the Effectiveness of U.S. Chemical Safety Laws." Subcommittee Chair Frank Lautenberg (D-NJ) last year introduced the Safe Chemicals Act of 2010, a bill that would have reformed the Toxic Substances Control Act (TSCA) by shifting the burden of proof to industry to show chemicals are safe, rather than the U.S. Environmental...

On January 18, 2011, U.S. Environmental Protection Agency (EPA) Administrator Lisa Jackson signed a proposed rule that would revise EPA's February 6, 2006, final rule concerning protections for subjects in human research. According to EPA, the proposed amendments would broaden the applicability of the rules to cover human testing with pesticides submitted to EPA under any regulatory statute it administers. The proposed amendments would also disallow participation in third-party pesticide studies...

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) published on January 19, 2011, a "plan containing 25 actions it intends to implement during 2011 to improve the most common path to market for medical devices." See FDA News Release, "FDA to improve most common review path for medical devices" (Jan. 19, 2011), available online. That path is the Premarket Notification, or 510(k) process, used for the bulk of medical device...

On January 7, 2011, the U.S. Consumer Product Safety Commission (CPSC) announced that it will hold two live web conferences on the publicly available consumer product safety information database. During the first web conference, scheduled for January 11, 2011, CPSC will demonstrate key functions of the database, such as how a consumer will be able to use the new online reporting form to submit a report of harm related to the use of a consumer product and how users can search...

The Acta Group, L.L.C.'s (Acta) thoughts are below on what may be headed our way in 2011 from the U.S. Environmental Protection Agency's (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). In short, the general trends established by the Obama Administration during the past two years are expected to continue notwithstanding the 2010 election results. At the same time, the impact of the election results, notably with the new Republican majority in the House of Representatives, will...

The California Department of Toxic Substances Control (DTSC) released a December 23, 2010, letter from Linda S. Adams, California's Secretary for Environmental Protection to Assembly Member Mike Feuer, the author of the 2008 law (A.B. 1879) that would require regulations to address chemicals and chemical ingredients in consumer products. In the letter, Secretary Adams responded to Feuer's letter outlining his concerns about the DTSC's November 16, 2010, release of revisions to its "Safer...

On December 6-7, 2010, the State Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Issues Research & Evaluation Group (SFIREG) held its semi-annual full committee meeting at the U.S. Environmental Protection Agency's (EPA) offices in Arlington, Virginia. Through a cooperative agreement in 1978, EPA and the Association of American Pesticide Control Officials (AAPCO) created SFIREG, an AAPCO committee with EPA funding, to promote information exchange and cooperation between the...

On December 17, 2010, the California Office of Environmental Health Hazard Assessment (OEHHA) issued proposed regulations that would specify hazard traits, environmental and toxicological endpoints, and other relevant data that are to be included in the Toxics Information Clearinghouse (Clearinghouse) the California Department of Toxic Substances Control (CDTSC) will develop. CDTSC will use information from the Clearinghouse to help identify chemicals of concern in consumer products as part of...

Korea has taken a major step toward achieving full compliance with the United Nations Globally Harmonized System (GHS) for the classification and labeling of chemicals by identifying 151 substances as "hazardous" for consultation. The Ministry of the Environment (MoE) in Korea also is placing more responsibilities on manufacturers and importers by introducing new rules regarding updating and content of material safety data sheets (MSDS). The MoE has given companies just ten days to comment on...

On December 9, 2010, the U.S. Consumer Product Safety Commission (CPSC) promulgated the final rule establishing a publicly available consumer product safety information database, as required by Section 212 of the Consumer Product Safety Improvement Act of 2008 (CPSIA). The database must be publicly available, searchable, and accessible through CPSC's website. CPSC's final rule interprets various statutory requirements pertaining to the information to include in the database, and establishes...

The U.S. Environmental Protection Agency (EPA) will announce in a Federal Register notice scheduled for publication on December 13, 2010, that it will hold a public information exchange meeting to receive comments and questions on the Nanomaterial Case Studies on January 4, 2011, in Research Triangle Park, North Carolina. According to EPA, the meeting will provide it an opportunity to highlight the Nanomaterial Case Studies and how EPA is using the...

Monday, December 20, 20101:30 p.m. - 3:30 p.m. (EST) Bergeson & Campbell, P.C. (B&C) is hosting a free webinar on endocrine disruptors on December 20, 2010. This webinar will provide an introduction to the issues associated with endocrine disruptors and testing strategies under the U.S. Environmental Protection Agency's (EPA) Endocrine Disruptor Screening Program (EDSP), while focusing on recent EPA developments that expand the regulatory scope beyond pesticide...

SAVE THE DATE January 27, 20111:00 - 5:30 p.m. (EST) NANO GOVERNANCE: THE CURRENT STATE OF FEDERAL, STATE, AND INTERNATIONAL REGULATION Please mark January 27, 2011, on your calendar for an exciting teleconference under development by the American Bar Association, Section of Environment, Energy, and Resources, Pesticides, Chemical Regulation, and Right-to-Know Committee. Program Overview: The Federal Regulatory Outlook  Beyond the Feds: International/State...

On September 21, 2010, the U.S. Food and Drug Administration (FDA) held a public hearing on the issue of labeling food made from the genetically engineered (GE) fish AquAdvantage Salmon, an Atlantic salmon produced by AquaBounty Technologies, Inc. The purpose of this hearing was to present the relevant legal principles for food naming and labeling, and describe information made available prior to the hearing about characteristics of AquAdvantage Salmon (e.g., the chemical composition...

We are pleased to announce that the NanoBusiness Alliance included Lynn L. Bergeson in its recent interview series. The interview covers a wide range of issues related to nanotech environmental, health and safety, including such "hot" topics as establishing a nano nomenclature that is uniform, thoughtful, and useful for regulatory purposes; the U.S. Environmental Protection Agency's (EPA) three Toxic Substances Control Act (TSCA) proposals that will have an immediate and significant impact on...

Bergeson & Campbell, P.C. is hosting a webinar on endocrine disruptors on December 20, 2010, at 1:30 p.m. (EST). This webinar will focus on recent developments in the area of endocrine disruptors, including the U.S. Environmental Protection Agency's (EPA) recent issuance of the second list of chemicals for Tier 1 screening, implications of the draft "weight-of evidence" and policies and procedures guidance documents, lessons learned from the first list of chemicals selected for Tier 1...

On November 24, 2010, the European Parliament (EP) overwhelmingly approved the proposed recast of the Restriction of Hazardous Substances (RoHS) Directive, which restricts the use of certain hazardous substances in electronic and electrical equipment (EEE). The RoHS Directive currently lists six materials as being restricted: lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls, and polybrominated diphenylethers. The EP passed by a vote of 640 to 3, with 12 abstentions,...

On November 16, 2010, the United States Department of Agriculture (USDA) Office of Risk-Assessment and Cost-Benefit Analysis (ORACBA) convened a Risk Forum on "Moving Beyond Nanogeneralities -- Providing Focus to Nanopolicy Progress." Presenters included Richard Canady, Ph.D., DABT, Director, Center for Human Health Risk Assessment Research Foundation of the International Life Sciences Institute; Steve Froggett, Expert Consultant, ICF International, Inc; and Guillaume Gruere, International Food...

On November 16, 2010, the California Department of Toxic Substances Control (CDTSC) released revisions to its safer consumer product alternatives regulations for a 15-day comment period. The proposed regulations pertain to the identification and prioritization of chemicals of concern in consumer products, evaluation of their alternatives, and regulatory responses for selected alternatives. CDTSC held a public hearing on November 1, 2010, during which it accepted written and oral testimony. In...